Alex Friedman, Senior Regulatory Affairs Specialist

Alex Friedman

SENIOR REGULATORY AFFAIRS SPECIALIST

Joined: September 21, 2026

Skills

Regulatory Strategies \| Software as a Medical Device (SaMD) \| Cloud-based \|Artificial Intelligence (AI) \| Machine Learning (ML) \| Cybersecurity \| FDA Submissions \| Regulatory Intelligence and Research \| Guidance documents assessments \| Compliance \| Post-market surveillance \| ISO 13485 \| ISO 14971 \| AAMI TIR34971 \| SOC 2 \|IEC 62304 \| IEC 60601 \| Labeling reviews \| Planning and Project Management \| Regulatory Intelligence \| Leadership \| Presentations \| Training \| Collaboration \| Cross-functional teaming \| Consensus building \| Creative problem solving \| EU MDR Technical Filing

Bio

Authentic regulatory professional who collaborates to gain the trust and respect of teammates and cross-functional stakeholders to achieve solid regulatory strategies and submissions. Experienced in submissions of low to moderate-high risk devices, and recognized as an expert in clinical decision support, mobile medical applications, digital health solutions and
AI/ML-enabled software. Experienced in collaborating between internal regulatory affairs departments and external vendors in support of product development, integration, product launch, premarket submissions/registrations and post-market compliance. Passionate about leveraging self- and team-expertise to provide direction to businesses, and proactively share
best practices, creative strategies and regulatory knowledge. Balances regulatory and business risks to accelerate best in class solutions to market, and total product lifecycle solutions to improve lives.

Hobbies

Family time, skiing, biking, reading, gardening (including vegetables)